Chemotherapy of advanced head and neck cancer with methotrexate, bleomycin, and cis-diaminedichloroplatinum II in an effective outpatient schedule

Vogel, Sinae; Kaplan, Bertha; Bingham, Hal G.

doi:10.1097/00006534-198002000-00110

Cited by 6 publications

(8 citation statements)

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“…served in phase I11 studies with the same treatments. A similar picture is evident with MTX, where the response We conducted a comprehensive review of the litera-rates reported in multiple studies range from 20% to ture for single agents and multiple chemotherapy combi-60% [37]. In 11 prospective randomized studies, the Table 111.…”

Section: Background a N D Rationalementioning

confidence: 82%

The application of a two‐stage design for clinical trials in patients with recurrent head and neck cancer

Eisenberger

Ellenberg

Leyland‐Jones

et al. 1988

Med. Pediatr. Oncol.

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Cytotoxic chemotherapy produces modest benefits for patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN). Prospective randomized clinical trials have failed to demonstrate unequivocal superiority of aggressive multidrug regimens over single agents. Despite this, phase II trials frequently result in encouraging preliminary observations that compare favorably to historical single-agent data. While providing for a useful method of screening for anti-tumor activity, phase II studies have limited use in determining the relative value of a new treatment program. Results of phase II studies are considerably influenced by patient selection factors and criteria used to establish therapeutic benefits (responses). Furthermore, estimations of true levels of efficacy (response rates) are dependent on sample sizes, which are usually limited in such trials. We propose that newly developed combinations containing at least one known active agent in this disease should be tested in a controlled setting after their toxicity pattern has been well established. The conduct of the usual phase II study in these situations will probably not provide useful new information, since responses are likely to be observed. We describe a two-stage design applied to terminate a trial if at the first stage there is no evidence of improvement over the control arm. This method allows for early termination of studies involving relatively inefficient treatment regimens and, at the same time, continuation of those with a high likelihood to result in significant therapeutic improvements over a control arm. Loss of power is negligible and sample sizes can be reduced significantly. The rationale behind this method and its simplicity are attractive features for a widespread application for new drug development strategies in this and other diseases.

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Section: Background a N D Rationalementioning

confidence: 82%

The application of a two‐stage design for clinical trials in patients with recurrent head and neck cancer

Eisenberger

Ellenberg

Leyland‐Jones

et al. 1988

Med. Pediatr. Oncol.

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“…It has been known that cisplatin and methotrexate combination chemotherapy is very effective in the control of squamous cell carcinoma of the head, neck, and esophagus [8,9]. The M-VAC regimen designed by Sternberg et al in 1985 was utilized [lo], resulting in a prompt and remarkable reduction in the size of the tumor described herein involving squamous cell carcinoma.…”

Section: Discussionmentioning

confidence: 99%

Retrovesical squamous cell carcinoma associated with toxoplasmosis: Diagnostic images, serum detection of SCC‐antigen, and successful treatment by M‐VAC regimen

Tada

Takeuchi

Tanaka

et al. 1989

Journal of Surgical Oncology

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A case of retrovesical squamous cell carcinoma associated with acquired toxoplasmosis is presented. To date only six cases with retrovesical carcinoma have been reported in the literature. Although it is difficult to make a preoperative diagnosis of this rare neoplasm, transrectal longitudinal ultrasonography was diagnostically valuable, and serial measurements of serum squamous cell antigen (SCC-Ag) were useful for monitoring the clinical course.

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“…The low complete re sponse rate (7%) despite of a 90% overall response may be due to the arbitrary limit of two courses of chemotherapy given to most patients and the need for pathological confirmation of a complete response in the surgical patients. The limited toxicity of this che motherapy regimen is also confirmed [14,19], The question of whether overall survival can be improved by the addition of this chemotherapy to surgery and/or radiation has not been resolved. Tu mor site of origin, stage, surgical expertise and patient selection factors all play important roles in determin ing treatment results in this disease [6, 11-13, 19, 28] and a historical comparison of our series with other similar studies would be meaningless.…”

Section: Discussionmentioning

confidence: 99%

“…All patients were initially given at least 2 cycles of chemotherapy as described by VogI and Kaplan [14] with methotrexate 40 mg/m2 i.m. on days I, 15; bleomycin 10 U i.m.…”

Section: Methodsmentioning

confidence: 99%

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Combination Chemotherapy prior to Definitive Local Therapy in Squamous Cell Carcinoma of the Head and Neck

Dj¹,

et al. 1985

Oncology

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30 patients with locally advanced squamous cell carcinoma of the head and neck were given chemotherapy with methotrexate, bleomycin and cis-Platinum prior to planned definitive surgery and/or radiation therapy. Chemotherapy was well tolerated and 90% of patients responded. Of 14 initially unresectable patients, 6 became operable after chemotherapy. After definitive therapy 70% of patients were considered complete responders, and 43% of the entire cohort remain disease-free. All partial responders have died. Patients receiving chemotherapy, surgery and radiation had a significantly greater likelihood of achieving a complete response than those receiving chemotherapy and radiation alone. Although this initial chemotherapy is highly active in this disease its contribution to ultimate survival is unclear. Overall treatment success is determined by the results of definitive therapy.

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Chemotherapy of advanced head and neck cancer with methotrexate, bleomycin, and cis-diaminedichloroplatinum II in an effective outpatient schedule

Cited by 6 publications

References 0 publications

The application of a two‐stage design for clinical trials in patients with recurrent head and neck cancer

The application of a two‐stage design for clinical trials in patients with recurrent head and neck cancer

Retrovesical squamous cell carcinoma associated with toxoplasmosis: Diagnostic images, serum detection of SCC‐antigen, and successful treatment by M‐VAC regimen

Combination Chemotherapy prior to Definitive Local Therapy in Squamous Cell Carcinoma of the Head and Neck

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